510(k) · Cleared

Cleared

Floret Tonsil & Adenoid Sponges

K830264510(k) TraditionalCleared Jun 3, 1983129-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ritmed, Inc. · EFQ Gauze/Sponge, Internal

Cleared on Jun 3, 1983 after a 129-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 30 later devices descend from it.

Decided: Jun 3, 1983
Review: 129 days
Class: Class U
Product code: EFQ
Recalls: None
Predicates: 0

30 later devices descend from it, 1 citing it directly.

This deviceK830264 Floret Tonsil & Adenoid SpongesRitmed, Inc. · 1983
Descendant · cites it directly · 29 of its ownK033666 HemadermMedafor, Inc. · 2003
Descendant · 2 generations on · 28 of its ownK070211 Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC · 2007
Descendant · 3 generations on · 19 of its ownK072900 Excelarrest FoamHemostasis, LLC · 2007
Descendant · 2 generations on · 11 of its ownK080818 Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc. · 2008
Descendant · 2 generations on · 9 of its ownK102459 Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical SpongeHemostasis, LLC · 2010

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2003high 4 (2014) · low 0 (2004)2026

Most influential descendants

Showing 5 of 30 · See all

K033666HemadermMedafor, Inc. · 2003 · cites it directly29descendants
K070211Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC · 2007 · 2 generations on28descendants
K072900Excelarrest FoamHemostasis, LLC · 2007 · 3 generations on19descendants
K080818Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc. · 2008 · 2 generations on11descendants
K102459Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical SpongeHemostasis, LLC · 2010 · 2 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K830264	Floret Tonsil & Adenoid Sponges	Ritmed, Inc.	1983	—
+1	K033666	Hemaderm	Medafor, Inc.	2003	—
+2	K070211	Traumarrest and Bleedarrest Hemostatic Particles and Foam	Hemostasis, LLC	2007	—
+3	K072900	Excelarrest Foam	Hemostasis, LLC	2007	—
+2	K080818	Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing	Hem Con Medical Technologies, Inc.	2008	—
+2	K102459	Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical Sponge	Hemostasis, LLC	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2007	2	0
2008	2	0
2009	1	0
2010	2	0
2011	1	0
2012	2	0
2013	2	0
2014	4	0
2015	2	0
2017	1	0
2018	3	0
2019	4	0
2021	1	0
2023	1	0
2024	1	0

FIG. 1 — Lineage of K830264, 1983–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EFQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (30)

See all 30

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K033666	Hemaderm	Medafor, Inc.	2003	29

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K033666 (Medafor, Inc., 2003) has gone furthest, with 29 descendants of its own.

How does its category compare?

All EFQ devices

EFQ Gauze/Sponge, Internal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EFQ

FDA has decided no EFQ device since 2007.

Median 510(k) review, days · EFQ

Too few EFQ 510(k)s in any year since 2007 to give a median.

Recalls per year · EFQ

3so far in 2026, the most since 2007

2007high 3 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EFQ

51in 2025

2007high 53 (2016) · low 0 (2008)2025

MAUDE reports naming product code EFQ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	4
2008	—	0	0
2009	—	0	4
2010	—	0	9
2011	—	0	6
2012	—	0	9
2013	—	0	8
2014	—	0	11
2015	—	0	27
2016	—	0	53
2017	—	0	8
2018	—	0	7
2019	—	0	5
2020	—	1	8
2021	—	0	6
2022	—	1	6
2023	—	0	10
2024	—	0	8
2025	—	0	51
2026	—	3	—

https://510kreport.com/device/K830264 · printed Nov 6, 2026

Cite this page

510(k) Report. “K830264: Floret Tonsil & Adenoid Sponges.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K830264

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026